Micro Labs USA

Job Profile - Manager Regulatory Affairs

Manager, Regulatory Affairs (Basking Ridge, NJ) - Review and prepare regulatory submission documents for the development and approval of generic pharmaceutical products in compliance with ANDA/CMC and 21 CFRs FDA guidelines; Review Master Batch Manufacturing/Packaging records, cleaning/process validation and Stability protocols, reports, PDR (Product development report) and eCTD; Review labeling and validations; Review FDA communications pertaining to ANDAs; Analyze, review, and manage DUNS and FEI databases in compliance with cGMP/FDA rules for all facilities; Research and optimize current practices of pharmaceutical research, pharmaceutical laboratory testing, pharmaceutical manufacturing, and all federal and state regulations for pharmaceutical product development in the U.S.; Plan and implement PLAIR and pharmaceutical product launch activities; Perform technology transfer and execution of Exhibit batches and process validation batches using QbD (Quality by Design); Review and ensure product listing and SPL (Structured Product Labeling) related activities adhere to relevant regulations; Review and ensure pharmaceutical product complaint processes in compliance with regulations; Monitor progress on audits and investigations; Conduct risk evaluation and quality audits.

Must have a Master's Degree in Pharmaceutical Chemistry, Industrial Pharmacy, or Pharmaceutical Manufacturing plus 2 years experience in job offered. Require skills and knowledge in ANDA/ CMC, eCTD, SPL/PDR, QbD, Cleaning/Process Validation, Master Batch Manufacturing/Packaging Records, Labeling, RAC.

Job location: Basking Ridge, NJ. This position is eligible for Employee Referral Program. Send resume referencing job code GAB003 to HR, Micro Labs USA, Inc., 106 Allen Road, Suite 102, Basking Ridge, NJ 07920.

Job Profile - Accounting Analyst- Project Coordinator

Accounting Analyst/Project Coordinator (Basking Ridge, NJ) - Analyzes financial status by collecting, monitoring, and studying data, recommending actions. Provide project management support during the implementation of SAP.

Accounting Job Duties:

  • Determines cost of operations by establishing standard costs; collecting operational data.
  • Identifies financial status by comparing and analyzing actual results with plans and forecasts.
    • Accounts Receivable - invoicing, credit / debit memos, cash applications, A/R follow-up, account reconciliation, A/R aging reports, cashflow, and daily sales and chargeback matching of SAP and 3PL
    • Accounts Payable - purchases, expense invoices, payments, A/P aging reports
    • Financial Reporting - general ledger analysis, gross-to-net calculations, month-end closing, P&L and Balance Sheet
  • Guides cost analysis process by establishing and enforcing policies and procedures; providing trends and forecasts; explaining processes and techniques; recommending actions.
  • Improves financial status by analyzing results; monitoring variances; identifying trends; recommending actions to management.
  • Bank reconciliation and reconciles transactions by comparing and correcting data.
  • Increases productivity by developing automated accounting applications, coordinating information requirements.
  • Contributes to team effort by accomplishing related results as needed.

Project Coordinator Job Duties:

  • Responsible for taking lead in planning, execution, monitoring & controlling of the project
  • Must have knowledge of Pharmaceutical Business Process
  • Define the requirements by discussing with all the users or user departments.
  • Define the deliverables and timelines for project
  • Prepare Project Plan & Monitor the Progress
  • Coordinate between all stakeholders like Implementation Partners, 3PL, Management & Users / Project Team
  • Single point of contact for outside vendor for the duration of project.
  • Prepare project status report & submit to management on defined intervals like Fortnightly or Monthly.

Skills and Qualifications:

This Full-Time position requires Bachelor degree in Accounting, with 3-5 years of experience in the generic pharmaceutical industry. The individual must have experience with Microsoft Office Suite, SAP required and EDI data transmission preferred. The individual must take ownership and demonstrate flexibility by being able to lead people and improve processes, work independently or in a team environment, prioritize responsibilities and manage multiple tasks. This position requires working effectively with others and good communication skills (both verbal and written). Corporate Finance, Developing Standards, Quality Management, Problem Solving, Process Improvement, Cost Accounting, Statistical Analysis, Financial Planning and Strategy, Reporting Research Results, Requirements Analysis, Financial Skills

NOTE: The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor to meet the ongoing needs of the organization.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing at its discretion.

Job Profile - Accounting Receivable Specialist

Accounting Receivable Specialist (Basking Ridge, NJ) - Analyzes financial status by collecting, monitoring, and studying data, recommending actions.

Job Duties:

  • Determines cost of operations by establishing standard costs; collecting operational data.
  • Identifies financial status by comparing and analyzing actual results with plans and forecasts.
    • Accounts Receivable - invoicing, credit / debit memos, cash applications, A/R follow-up, account reconciliation, A/R aging reports, cashflow, and daily sales and chargeback matching of SAP and 3PL
  • Improves financial status by analyzing results; monitoring variances; identifying trends; recommending actions to management.
  • Bank reconciliation and reconciles transactions by comparing and correcting data.
  • Increases productivity by developing automated accounting applications, coordinating information requirements.
  • Contributes to team effort by accomplishing related results as needed.
  • Posts customer payments by recording cash, checks, and credit card transactions.
  • Posts revenues by verifying and entering transactions form lock box and local deposits.
  • Updates receivables by totaling unpaid invoices.
  • Verifies validity of account discrepancies by obtaining and investigating information from sales, trade promotions, customer service departments, and from customers;
  • Resolves valid or authorized deductions by entering adjusting entries.
  • Resolves invalid or unauthorized deductions by following pending deductions procedures.
  • Resolves collections by examining customer payment plans, payment history, credit line
  • Summarizes receivables by maintaining invoice accounts; coordinating monthly transfer to accounts receivable account; verifying totals; preparing report.
  • Protects organization's value by keeping information confidential.
  • Accomplishes accounting and organization mission by completing related results as needed.

Skills and Qualifications:

This Full-Time position requires Bachelor degree in Accounting, with 3-5 years of experience in the generic pharmaceutical industry. The individual must have experience with Microsoft Office Suite, SAP required. The individual must take ownership and demonstrate flexibility by being able to lead people and improve processes, work independently or in a team environment, prioritize responsibilities and manage multiple tasks. This position requires working effectively with others and good communication skills (both verbal and written). Corporate Finance, Developing Standards, Quality Management, Problem Solving, Process Improvement, Cost Accounting, Statistical Analysis, Financial Planning and Strategy, Reporting Research Results, Requirements Analysis, Financial Skills

NOTE: The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor to meet the ongoing needs of the organization.

We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing at its discretion.